Though new software and other technologies can hugely improve safety and efficiency in healthcare by automating and preprogramming some of the most precise processes in a hospital, there are also certain safety risks inherent to putting our trust in the hands of machines.
Namely, when those machines break or malfunction, not only can it be difficult to recognize the cause of the high-tech issue, but there’s also often a learning gap between previous manual processes and the machine’s way of doing them, making it difficult for humans to pick up the slack.
These and other risks are at the core of a safety recall launched in July by Baxter, after a defect was discovered in its Dose IQ software that could potentially cause it to transmit incorrect drug dosing information to the company’s Spectrum IQ infusion pumps.
As of this week, the FDA has designated the recall as Class I, the most serious of the agency’s ratings, denoting a possibility of serious injury or death.
Dose IQ was designed to smooth out the process of administering medications via the Spectrum IQ system. Healthcare providers program their own drug libraries into the software, along with dosing and delivery specifications, so that once a patient is connected to an infusion pump, they can automatically begin receiving the correct type and dosage of a medication with only the touch of a few buttons or by scanning a barcode.
In some cases, however, a defect in version 9.0.x of the software causes the information in those preprogrammed libraries to become mismatched, potentially causing improper configuration of requested medications. That misconfiguration, in turn, could lead to either a delay in treatment or an under- or over-infusion of medication.
So far, no injuries or deaths have been linked to the issue, but the FDA said it has received 15 complaints about the software to date.
A total of 61 software systems installed in hospitals and other healthcare facilities across the U.S. are included in the recall, which covers all drug libraries that were created using the system’s version 9.0.x.
Baxter is currently developing a new software tool to patch up the defect, which will be rolled out to affected facilities—alongside an upgrade to Dose IQ version 9.1.1 or higher—as soon as it’s ready.
In the meantime, providers are asked to pay especially close attention to their infusion pumps’ preprogrammed dosing and delivery information. If the correct configuration isn’t showing up on the pump, they should report it to their pharmacy department and proceed to manually program the pump in basic mode.
The recall comes a little over a year after Baxter issued another Class I recall for the combined Spectrum IQ and Dose IQ system. In that case—which also affected its Sigma line of infusion pumps and their own Master Drug Library—the infusion systems were recalled because they were found to be at risk of sudden and unexpected shutdowns if improper cleaning had caused residue buildup or corrosion within the device.
That recall covered more than 550,000 devices distributed throughout the U.S., sparked nearly 17,500 complaints and was linked to at least 16 reports of serious injuries, per the FDA.